BS EN ISO 18778:2009 - Respiratory equipment. Infant monitors. Particular requirements – BSI British Standards

BS EN ISO 18778:2009

Respiratory equipment. Infant monitors. Particular requirements

Status : Under review, Current   Published : July 2009



BS EN ISO 18778:2009 Respiratory equipment. Infant monitors. Particular requirements

BS EN ISO 18778 specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age.

BS EN ISO 18778 applies to devices used in home care applications. These monitors are generally used without continual professional supervision. BS EN ISO 18778 also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.

BS EN ISO 18778 does not apply to monitors intended for use in health care facilities/institutions. The requirements of BS EN ISO 18778, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.

Contents of BS EN ISO 18778:

  • Foreword
  • Introduction
  • Scope
  • Normative references
  • Terms and definitions
  • General requirements and general requirements for tests
  • ClassificationIdentification, marking and documents
  • Power input
  • Basic safety categories
  • Removable protective means
  • Environmental conditions
  • Not used
  • Not used
  • General
  • Requirements related to classification
  • Limitation of voltage and/or energy
  • Enclosures and protective covers
  • Separation
  • Protective earthing, functional earthing and potential equalization
  • Continuous leakage currents and patient auxiliary currents
  • Dielectric strength
  • Mechanical strength
  • Moving parts
  • Surfaces, corners and edges
  • Stability in normal use
  • Expelled parts
  • Vibration and noise
  • Pneumatic and hydraulic power
  • Suspended masses
  • X-Radiation
  • Alpha, beta, gamma, neutron radiation and other particle radiation
  • Microwave radiation
  • Light radiation (including lasers)
  • Infrared radiation
  • Ultraviolet energy
  • Acoustical energy (including ultrasonics
  • Electromagnetic Compatibility
  • Locations and basic requirements
  • Marking and accompanying documents
  • Common requirements for category AP and category APG equipment
  • Requirements and tests for category AP equipment, parts and components thereof
  • Requirements and tests for category APG equipment, parts and components thereof
  • Excessive temperatures
  • Fire prevention
  • Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
  • Pressure vessels and parts subject to pressure
  • Human errors
  • Electrostatic charges
  • Biocompatibility
  • Interruption of the power supply
  • Accuracy of operating data
  • Protection against hazardous output
  • Abnormal operation and fault conditions
  • Environmental tests
  • General
  • Enclosures and covers
  • Components and general assembly
  • Mains parts, components and layout
  • Protective earthing – Terminals and connections
  • Construction and layout
  • Additional requirements
  • Rationale
  • Environmental aspects
  • Index of defined terms
  • Bibliography

Standard NumberBS EN ISO 18778:2009
TitleRespiratory equipment. Infant monitors. Particular requirements
StatusUnder review, Current
Publication Date31 July 2009
Confirm Date30 September 2013
Normative References(Required to achieve compliance to this standard)ISO 15001:2003, IEC 60068-2-32:197, IEC 60529:2001, IEC 60068-2-32:1975/AMD 1:1990, IEC 60601-1:1988/AMD 1:1991, IEC 60601-1:1988/Corrigendum:1995, IEC 60079-4:1975, IEC 60601-1:1988/AMD 2:1995, EN 71-1:1998/AMD 1:2001, ISO 9919, ISO 4135:2001, IEC 60601-1-2:2001, IEC 60068-2-32:1975/AMD 1:1982, IEC 60068-2-32:1975, IEC 60601-2-27:1994, IEC 60601-1:1988, EN 1041:1998, IEC 60068-2-64:1993, IEC 60601-2-23:1999, EN 980:2003, ISO 7000, EN 71-1:1998
Informative References(Provided for Information)93/42/EEC, NFPA 53M, EN 60601-1-8, IEC 60601-1-6
ReplacesBS EN ISO 18778:2005
International RelationshipsISO 18778:2005,EN ISO 18778:2009
DescriptorsMedical equipment, Patient monitors, Medical breathing apparatus, Infants, Electrical medical equipment, Breathing apparatus, Children, Monitors, Domestic
Title in FrenchMatériel respiratoire. Moniteurs pour enfants. Exigences particulières
Title in GermanBeatmungsgeräte. Überwachungsgeräte für Kleinkinder. Besondere Anforderungen
ISBN978 0 580 65561 6
File Size1 MB

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